Synchronous Percutaneous Facet Radiofrequency and Spinal Fixation With Epidural Injection Therapy as a Management for Persistent Radicular Pain After Microdiscectomy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Change in Pain Intensity (NRS)
研究概览
简要总结
This interventional study evaluates a "triple therapy" approach-combining percutaneous spinal fixation, facet radiofrequency ablation, and epidural steroid/hyaluronidase injection-for patients with Failed Back Surgery Syndrome (FBSS). The study compares this combined strategy against spinal fixation alone to determine its effectiveness in reducing chronic radicular pain and disability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 23 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with persistent back pain after microdiscectomy (FBSS).
- •Failure of conservative treatment for at least six months.
- •Positive results on a diagnostic lumbar facet nerve block.
排除标准
- •Spinal instability, fractures, or spondylolisthesis.
- •Severe psychiatric disorders.
- •Baseline ODI score higher than 60%.
- •Opioid users or history of adverse reactions to steroids.
研究组 & 干预措施
Triple Therapy Group
Patients with failed back surgery syndrome who receive a combined intervention consisting of thermal radiofrequency ablation of the medial branch, percutaneous spinal fixation (Sextant system), and an epidural injection of triamcinolone mixed with hyaluronidase.
干预措施: Epidural Injection (Drug)
Triple Therapy Group
Patients with failed back surgery syndrome who receive a combined intervention consisting of thermal radiofrequency ablation of the medial branch, percutaneous spinal fixation (Sextant system), and an epidural injection of triamcinolone mixed with hyaluronidase.
干预措施: thermal Radiofrequency Ablation (Procedure)
Triple Therapy Group
Patients with failed back surgery syndrome who receive a combined intervention consisting of thermal radiofrequency ablation of the medial branch, percutaneous spinal fixation (Sextant system), and an epidural injection of triamcinolone mixed with hyaluronidase.
干预措施: Spinal Fixation (Procedure)
Triple Therapy Group
Patients with failed back surgery syndrome who receive a combined intervention consisting of thermal radiofrequency ablation of the medial branch, percutaneous spinal fixation (Sextant system), and an epidural injection of triamcinolone mixed with hyaluronidase.
干预措施: ELISA (Diagnostic Test)
Spinal Fixation Only
Patients with failed back surgery syndrome who undergo percutaneous spinal fixation only, using the Sextant system to stabilize the adjoining vertebrae.
干预措施: Spinal Fixation (Procedure)
Spinal Fixation Only
Patients with failed back surgery syndrome who undergo percutaneous spinal fixation only, using the Sextant system to stabilize the adjoining vertebrae.
干预措施: ELISA (Diagnostic Test)
Healthy Control
A cross-matched group of healthy volunteers used solely as a baseline reference for serum inflammatory cytokine levels.
干预措施: ELISA (Diagnostic Test)
结局指标
主要结局
Change in Pain Intensity (NRS)
时间窗: 6 months post-intervention
Assessment of back and radicular pain using the 10-point Numeric Rating Scale (NRS)(Score on a scale of 0 to 10)
Change in Disability Level (ODI)
时间窗: 6 months post-intervention
Measurement of functional disability using the Oswestry Disability Index (ODI).
次要结局
- Serum Concentration of Pro-inflammatory Cytokines (TNF-α)(6 months post-intervention)
研究者
Adel Farag Al Kholy
Professor of Medical Biochemistry
Benha University